What are the S88 recipe types?

General, Site, Master, and Control. The Master recipe is the governed template; the Control recipe is the executed instance bound to equipment and parameters.

How do I manage scaling and potency?

Use governed parameter sets with recipe scaling basis and potency/assay adjustments so scaling math resides in recipes, not PLC code.

ISA-88 (S88) – Batch Control StandardGlossary

ISA‑88 (S88) – Batch Control Standard

Q: How is S88 different from S95?

S88 structures batch control inside units with phases, modules, and recipes. S95 structures enterprise-to-operations integration for orders, resources, and events. They are complementary.

Q: Do I need MES to implement S88?

S88 can run on PLC/SCADA, but MES provides recipe governance, genealogy, eBMR integrity, and inspection-ready evidence.

Q: Where should interlocks live—phase or module?

Put safety and device-protective interlocks in equipment/control modules; keep business logic and sequence in phases/recipes.

Q: Can S88 support cleaning validation?

Yes. Implement reusable CIP/SIP phases tied to cleaning validation acceptance, record evidence in the eBMR, and block execution until acceptance is met.

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated October 2025 • Equipment/Control Modules, Phases & Recipes, Mode/State Management • Manufacturing, QA/RA, Automation

ISA‑88 (S88) is the de‑facto architecture for batch control. It separates what you want to do (recipes and procedural logic) from how equipment is wired and driven (equipment/control modules), so processes can evolve without re‑writing PLC code every time marketing tweaks a formula. S88 defines the physical model (process cell → unit → equipment module → control module), the procedural model (procedure → unit procedure → operation → phase), and the recipe model (general, site, master, control) that turns approved MBR/MMR content into executed, device‑tight work under MES/SCADA with defensible eBMR evidence.

“If your ‘recipe’ lives in ladder logic, you don’t have flexibility—you have a hostage.”

TL;DR: S88 modularizes batch control: recipes run as phases & equipment modules on validated units, with mode/state management, interlocks, and parameter governance. Keep formula/sequence changes in governed recipes (recipe versioning), device logic in modules, and prove execution with eBMR under Part 11/Annex 11. No copy‑paste PLC edits. No shadow spreadsheets.

1) What S88 Covers—and What It Does Not

Covers: a modular control architecture for batch/semicontinuous operations: physical/equipment hierarchy, procedural decomposition, recipe types, parameter sets, and mode/state behavior. It governs how phases bind to devices and how operators interact via HMI and MES. Does not cover: enterprise planning (that’s ISA‑95), or relieve you from validation/data‑integrity obligations. S88 is structure; GMP is law.

2) Legal, System, and Data Integrity Anchors

Regulated batches demand auditable control. Electronic records and signatures must meet Part 11/Annex 11; systems are validated under CSV/GAMP 5; data is ALCOA(+); and devices show calibration status. S88 helps you separate change types: recipe edits route through Change Control and approval workflows, while module logic changes trigger impact analysis and re‑qualification (IQ/OQ/PQ).

3) The S88 Evidence Pack

A complete evidence pack shows: physical model (process cells/units/modules), procedural model (unit procedures/operations/phases), recipe hierarchy (general/site/master/control), parameter libraries with limits and units (UOM), interlock/permissive definitions, mode/state tables (manual/auto; running/held/stopped), audit trails, and example eBMR runs proving parameter application, exceptions, and QA release under Release Status.

4) From Recipe to Execution—A Standard S88 Path

1) Author & Approve. Build a governed master recipe from process knowledge, risks (PFMEA), and SOPs.
2) Bind & Stage. Allocate units and equipment modules; ensure materials are staged via WMS with Hold/Release and FEFO/FIFO.
3) Execute. Operators run the control recipe; phases call equipment modules with interlocks and limits enforced; exceptions open Deviations as needed.
4) Assure & Release. IPC and lab results flow from LIMS to the eBMR; QA reviews evidence and dispositions.

If a prerequisite fails (calibration, training, wrong lot, stale recipe), block the phase and record the stop—no manual bypasses that the BMR can’t defend.

5) Designing Phases & Equipment Modules—A Practical Method

Decompose operations into reusable phases (e.g., HeatTo, Hold, Agitate, Dose, Transfer, CIP) that call equipment modules (valves, drives, scales, pumps) and expose parameters and limits. For each phase define: inputs (setpoints, tolerances, timers), interlocks/permissives, modes (auto/semi/manual), states (idle/running/held/aborted), alarms, and data captures. Keep business rules (yield logic, label triggers) in MES; keep device safety in modules/PLC. Parameterize quantities using recipe scaling & basis so batch size changes don’t require code edits.

6) Measurement, Dosing & Uncertainty

Phases are only as good as their sensors. Tie dosing phases to verified scales and feeders: load cells, GIW/LIW, macro and micro‑ingredient dosing. Validate methods (TMV) and quantify bias/noise via MSA. For reactors, embed temperature/pressure ramp integrity and hold timers (batch reactor) with permissives for agitation and utilities (UQ).

7) Data Integrity—Proving Compliance Without Recode

Record raw reads and computed values in the eBMR: actual curves, dosing traces, mass totals (mass balance), and labels issued/verified. Store recipe version, parameter sets, and overrides with audit trails and approval workflows. If a phase timer or limit is edited, the who/why must be evident. Keep calculations inside validated systems—no spreadsheet brokers.

8) Scheduling, Materials & Lab Cross‑Checks

S88 plays nicely with finite‑capacity scheduling and WMS staging. Staged lots must match recipe requirements and status (Component Release). Build phases that hand off to LIMS for samples and wait properly for results (with timeouts/escalations). Sustained bias between inline signals and lab means instrumentation or method issues—stop and fix under CAPA.

9) Mode/State, Interlocks & Drift

Implement clear mode transitions (manual/semi/auto) and states (idle/running/held/aborted) with safe behavior for holds and aborts. Interlocks must be explicit (e.g., valve closed before pump start; vent open before heat). If drift is detected (e.g., scale zero wandering, temperature overshoot), make it visible as a capability signal in the eBMR and gate release until addressed via RCA.

10) Labels, Claims & Downstream Truth

Phases that result in pack/label events must pull from governed masters and print through verified pipelines (Label Verification), including serialization/SSCC where applicable. For cosmetics/devices, tie claims and ingredient declarations to INCI and ISO 22716; for chemicals, reflect GHS/SDS hazard communication.

11) Changeovers, CIP/SIP & Cross‑Contamination

Build reusable cleaning phases (CIP/SIP) with recipe‑driven parameters and verification steps linked to cleaning validation. Enforce equipment/recipe compatibility rules and preventives for cross‑contamination. Record cleaning results, swab IDs, and acceptance in the eBMR before the next unit procedure starts.

12) SPC & CPV in Procedural Control

Track critical parameters with SPC; apply runs/trend rules and compute Cp/Cpk. Feed evidence to CPV and link sustained excursions to control plan adjustments. The aim is stable, small‑variance execution—not heroics at release.

13) Metrics That Demonstrate S88 Control

Recipe Right‑First‑Time and release lead time (end of last phase → QA disposition).
Phase Repeatability (duration/overshoot variance) across campaigns and units.
Exception Rate per 100 phases (held/aborted/override).
Label/Record Parity incidents for packaging phases.
Mass‑Balance Error and yield variance by operation/unit.
Calibration/Method Blocks that prevented bad runs (a feature, not a bug).

These KPIs connect control architecture quality to compliance posture and financial impact (yield, cycle time, scrap).

14) Common Pitfalls & How to Avoid Them

Embedding recipe in PLC logic. Changes become CAPA magnets—move sequence/parameters into governed recipes.
One‑off phases. Build libraries; reuse everywhere; version properly.
Anonymous overrides. Enforce roles, signatures, and justification prompts.
Dual masters. Mismatch in codes/UOM across ERP/MES/WMS—govern under Document Control.
Copy‑paste labels. Print from execution truth and verify with Label Verification.
“We’ll reconcile in QA.” You’ll reconcile into scrap—design prevention into phases.

15) What Belongs in the S88 Recipe Record

Include physical and procedural models, master/control recipe versions, parameter sets with limits and units, equipment allocations and eligibility, phase definitions with interlocks/modes/states, cleaning phases and acceptance, sampling triggers and methods, data capture definitions, audit trails, training/role prerequisites, and approvals/effective dates under Document Control. Retain per record retention rules aligned to product life and regulation.

16) How This Fits with V5 by SG Systems Global

Phase Library & Governance. The V5 platform manages a reusable library of S88 phases and equipment modules under versioned Document Control; changes route through approvals with full audit trail.

Device‑Tight Execution. V5 binds phases to verified devices (scales, feeders, reactors, drives), enforces calibration status and role/training gates, and blocks execution when prerequisites fail.

Integrated Quality & Labels. V5 exchanges samples/results with LIMS, renders labels from the same execution truth, verifies prints, and rolls evidence into the eBMR.

Evidence‑Based Release. Dashboards expose phase repeatability, exception rates, and recall readiness; QA releases on evidence—no side files, no PLC spelunking. Bottom line: V5 makes S88 practical, scalable, and inspection‑ready.

17) FAQ

Q1. How is S88 different from S95?
S88 structures batch control inside process cells/units (phases, modules, recipes). S95 structures enterprise‑to‑operations integration (orders, resources, events). Use both.

Q2. Do I need MES to implement S88?
You can run S88 with PLC/SCADA alone, but you’ll lack recipe governance, genealogy, and eBMR integrity. MES makes S88 auditable and scalable.

Q3. What are the core S88 recipe types?
General → Site → Master → Control. Master is your governed template (akin to MBR); Control is the executed instance bound to units and parameter sets.

Q4. Where should interlocks live—phase or module?
Put safety‑critical interlocks in equipment/control modules (closest to the device). Keep business logic and sequence in phases/recipes.

Q5. How do I handle scaling and potency adjustments?
Use governed parameter sets with scaling basis and, when required, potency/assay adjustments so the recipe—not the PLC—does the math.

Q6. Can S88 help with cleaning validation?
Yes—implement reusable CIP/SIP phases tied to cleaning validation acceptance, record evidence in the eBMR, and block next unit procedures until acceptance is met.